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Identify and resolve three ethical issues that are raised by a biomedical scenario

Identify and resolve three ethical issues that are raised by a biomedical scenario

Scenario:

Danny Peters is a researcher who works in the field of mitochondrial disease. He is opposed to speciesism, which is why he thinks that biomedical research on nonhuman animals should only be allowed where it would be acceptable to do the research on human beings.

Danny is keen to further his research on mitochondrial disease, which is why he approaches Rosie, a specialist in reproductive medicine. Danny explains that he needs more human egg cells for his research, and he offers to pay £ 500 per treatment cycle to any woman aged between 21 and 35 who is willing to provide eggs.

Rosie decides to help out Danny and advertises the study. Kim responds to Rosie’s advert. After receiving information about the research and what is potentially required from her, she explains that she does not understand what the research is about, but that she would nevertheless like to participate. Rosie thinks that Kim might lack capacity, which is why she decides to provide more information about the study. Finally, she offers her a consent form, which is signed by Kim.

Danny and Rosie both must abide by legal and ethical rules to recruit participants and perform the study. Speciesism was a term popularised by Peter Singer and is the practice of treating one species as morally superior to another. This is determined by the cognitive capacity presented by each species. As humans have superior intellect, they are deemed to have a higher moral status when compared to other species (Singer, 2009). Danny is opposed to speciesism, believing that non-human animals should be treated as human animals would be treated. Danny also offers £500 as a reward to participants. This is a mild form of coercion or irrational persuasion. Coercion is the idea of applying undue pressure on a person to participate in trials/treatment etc. Danny would not be applying undue pressure on people but providing a £500 reward can be an incentive when deciding to donate the egg cells. Thorough deliberation as to the nature of consent is required (Wiles et al., 2005). A participant must have the mental capacity to consent to a trial. The Mental Capacity Act 2005 (MCA) states that a consenter is unable to make their own decision if they cannot understand the information given to them. Kim does not understand the research and it is not confirmed whether she understands the risks of egg cell donation after Rosie provides more information. Kim’s consent could be questioned as she may fail the two-stage capacity test.

Speciesism

Danny is against speciesism, believing that humans and animals should be treated equally. However, some researchers do practise speciesism. They have a belief that novel research should be observed on smaller animals to test for safety before investigating on humans. These researchers address the deontological theory of Kantian utilitarianism: the ends justify the means. The intentions of the research outweigh the methods used, whether this includes animal trials or not. Humans deserve a higher moral right to safety when compared to other species (Deckers, 2017). However, people can oppose this belief with the theory of sentience: non-human animals still have the capability to feel. Panexperientialists believe that everything down to subatomic particles have the capability to feel, the same subatomic particles that create non-human animals.

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Many say speciesism is the same as racism, sexism and other forms of prejudice which are criminal offences. Speciesism is based on discrimination against a being, due to it being part of a species. Singer (2009) argues that all beings capable of suffering should be given equal consideration. If they are not, then it is the same as discrimination based on gender or skin colour. However, minorities were given the right to vote as they can make rational decisions. Animals cannot make rational decisions and thus do not get the same rights, mainly due to them not being able to speak. This can be countered with the fact that animals have a process of executive functioning within their brains, which can be tested for, allowing them to make their own relative rational decisions (Mesaroş, 2014).

Speciesists can also argue essentialism. All beings have attributes that can be used to identify them. Essentialism is a theme in many major religions around the world. This encompasses the belief that only humans have been created in the image of God and that animals were put on Earth only to serve humans. This is an example of moral absolutism (Newman and Knobe, 2019). Species essentialists would say that Danny should refrain from using human eggs as animal options would be less harmful to humans.

Speciesism can be resolved with a matched graduated view on moral status of humans and animals. Moral status is defined by cognitive ability, but this could be replaced with a combination of different factors which could include some aspects of cognitive ability (Singer, 2009). Laboratory animal welfare has been considered and laws to replace, reduce and refine animal research have been passed. Animals (scientific procedures) Act (ASPA) was passed in 1986 and revised in 2012 to replace animals in the laboratory wherever possible, to limit the number of animals used to the minimum and to increase the care and protection of these animals. To reduce the impact of any speciesism, Danny could use induced pluripotent stem (iPS) cells which only requires skin cells. They can be programmed to differentiate into egg cells. He could refrain from using iPS cells due to the expense but grants and the £500 reward per treatment cycle could assist him. Danny could refrain from any in vivo/in vitro research and pursue his research in silico where advances are being made in mitochondrial research (Bacalhau et al., 2017; Nelms et al., 2015).

Reward

Danny is willing to offer £500 to participants which is deemed controversial. The Nuremberg Code of 1947 states that participants should not be put under any pressure to join research trials. In this regard, the incentive of £500 is coercive (BMJ, 1996). Coercion is defined as using force to persuade a person. Money is not deemed to be a threat and thus cannot be coercive. However, it is undue influence. The money can be a temptation and compel volunteers whilst compromising their thinking during the consent process (Grady, 2001).

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Financially disadvantaged participants might be more vulnerable to this type of coercion as they need the money. Kim is keen to join the trial without understanding the research which could be due to the reward. This affects her autonomy. However, a financial reward usually increases the number of participants which provides Danny with more egg cells. Donating egg cells is a big commitment and a reward system may be warranted. If Danny has the capability to pay for participation in his research, and each participant is ethically and medically allowed to partake, then there is nothing to stop him paying.

Kim must be fully informed before she consents. Guidelines should be used when deciding how and when the payment is made. Danny must provide ethics committees with a clear justification for the reward and the ethics committee must accept this justification before it is advertised. Careful consideration must be taken in to whether Kim is consenting for the money. In this case, she must be explicitly reminded of the risks, benefits and requirements of the study and have the opportunity to withdraw. If she returns for repeat treatments, then the reasoning for consent must be considered. Payment should not supersede the ethics of informed consent which Danny should remember. Rewards can be reduced to vouchers or food to decrease the coercive impact on participants.

Capacity

Part of the consent process is being fully informed and having the capacity to understand the risks of participation in a trial. Kim shows incapacity but is willing to consent, suggesting a lack of autonomy (Coggon, 2016). The Mental Capacity Act states that a person should pass the two-stage test to be considered to participate in the trial. It is not confirmed whether Rosie assesses Kim’s mental capacity even though she does provide more information. Rosie also has a duty to provide the required information to Kim’s level of understanding. Kim needs to understand the risks associated with egg cell donation. The method of retrieval is invasive and can cause discomfort, bleeding and infection. The fertility drugs can cause ovarian hyperstimulation syndrome, mood changes and mild weight gain.

Kim’s lack of understanding will cause her to fail the second stage of the mental capacity test. The information that Rosie provides may not be enough for her to decide. Other factors, such as the reward mentioned earlier, may have an impact on her decision. However, the MCA applies to people aged 16 or older. Kim is between the ages of 21-35 and it is presumed that she has the capacity to make an autonomous decision, as the Family Law Reform Act 1969 states. Rosie and Danny must respect this.

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Kim’s capacity should be assessed by Rosie before handing her a consent form. She needs to check if Kim understands the information required to consent and needs to show that she can appreciate the consequences of her decision. The Human Tissues Act of 2004 states that a researcher requires appropriate consent from the donor, and if the person lack capacity then appropriate consent cannot be given which is a punishable offence.

Conclusion

Speciesism is a very large topic of debate. It causes people to rethink their beliefs about the moral status of non-human animals. Danny’s views on speciesism are reasonable due to the arguments of capacity and sentience. However, if speciesism is to be rejected, the capacities that form the basis of the moral status shared by humans and animals must be regulated. Gaining informed consent from a trial participant is a difficult process. Rosie need to consider a wide range of study-related issues that must be portrayed to Kim, as well as ensuring the level of consent is appropriate. Capacity can be the gateway to autonomy, but autonomy is not always the gateway to capacity; autonomy is insufficient of freedom from external influences like rewards. They are assisted with these decisions as consent is driven by legal (MCA 2005) and ethical (ethical committees) frameworks which regulate the processes of consent and reward justification.

Word Count: 1493

References:

Bacalhau, M., Pratas, J., Simões, M., Mendes, C., Ribeiro, C., Santos, M., Diogo, L., Macário, M. and Grazina, M. (2017). In silico analysis for predicting pathogenicity of five unclassified mitochondrial DNA mutations associated with mitochondrial cytopathies’ phenotypes. European Journal of Medical Genetics, 60(3), pp.172-177.

Coggon, J. (2016). Mental Capacity Law, Autonomy, and best Interests: An Argument for Conceptual and Practical Clarity in the Court of Protection. Medical Law Review, 24(3), pp.396-414.

Deckers, J. (2017). Why “Animal (De)liberation” survives early criticism and is pivotal to public health. Journal of Evaluation in Clinical Practice, 23(5), pp.1105-1112.

Grady, C. (2001). Money for Research Participation: Does It Jeopardize Informed Consent? American Journal of Bioethics, 1(2), pp.40-44.

Mesaroş, C. (2014). Aristotle and Animal Mind. Procedia – Social and Behavioral Sciences, 163, pp.185-192.

Nelms, M., Mellor, C., Cronin, M., Madden, J. and Enoch, S. (2015). Development of an in Silico Profiler for Mitochondrial Toxicity. Chemical Research in Toxicology, 28(10), pp.1891-1902.

Newman, G. and Knobe, J. (2019). The essence of essentialism. Mind & Language.

See Peter Singer (1989) All Animals are Equal in Keller, D. (2010). Environmental ethics. Chichester, West Sussex: Wiley-Blackwell, pp169-175.

SINGER, P. (2009). SPECIESISM AND MORAL STATUS. Metaphilosophy, 40(3-4), pp.567-581.

The Nuremberg Code (1947). (1996). BMJ, 313(7070), pp.1448-1448.

Wiles, R., Heath, S., Crow, G. and Charles, V. (2005). Informed Consent in Social Research: A Literature Review. NCRM Methods Review Papers, [online] pp.1-26.

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